In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 1 ( 2021-03-18), p. 48-61
Abstract:
The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease. In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan & USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v9i1.455
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2021
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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